Glossary API to Vehicle

• Active pharmaceutical Ingredient


  Any substance intended to be used in the compounding of a preparation as an active ingredient that has a direct effect on its use
• Added substance


  Necessary for compounding a preparation but has no direct effect on its uses
• Administration


  The preparation of a nonsterile pharmacologic for providing a non sterile medicine in its final form
• Alcohol-based hand rub


  An alcohol containing preparation designed for application to the hands to inactivate microorganisms
• Assigned trainer


  A person that is given the accountability for providing training, observations, and evaluation to personnel
• Beyond-use date


  A date or time which a CNSP should not be used, stored, or transported, which is based on when it was compounded
• Biological safety cabinet


  Ventilated cabinet used for compounding
• Certificate of analysis


  A report from the supplier of a component, container, or closure that accompanies the supplier's material and contains the analysis of the materials
• Cleaning


  The process of removing substances from objects
• Cleaning agent


  Agent that contains a surfactant used for the removal of substances from surfaces
• Closed system processing device


  Used to reduce potential exposure to personnel or contamination of the facility
• Component


  Any ingredient used in a compounding of a preparation
• Compounded nonsterile preparation


  A preparation not intended to be sterile made by combining, admixing, diluting, etc.
• Compounding


  The process of combining, admixing, diluting, reconstituting, etc. Altering a product or bulk drug product
• Compounding area


  Area specifically for nonsterile compounding
• Compounding personnel


  Personnel trained to compound or oversee compounding of preparations
• Compounder


  A professional authorized by the appropriate jurisdiction to perform compounding pursuant to a prescription ordered by a prescriber
• Compounding record


  Documents the compounding of each CNSP
• Container closure system


  Package system components that together contain and protect the dosage form
• Containment glove bag


  Single use disposable bag that can contain chemical particles
• Containment ventilated enclosure


  A full or partial enclosure that uses ventilation principles to capture, contain, and remove airborne contaminants
• Conventionally manufactured product


  A pharmaceutical dosage form, usually the subject of an application approved by the national agency
• Designated persons


  Individual assigned to be responsible and accountable for the performance and operation of the facility and personnel
• Formulation


  Specific composition of the final CNSP
• Hazardous drug


  Identified by carcinogenicity, genotoxicity, and toxicity in humans
• Label


  Labelling on the container
• Master formulation record


  Detailed record of procedures of how a CNSP was prepared
• Monograph


  Quality document, a standard by the USP-NF that states the quality expectations for a medicine
• Oversight


  Review, monitoring, and supervision of actions taken by the personnel
• Preservative


  Substance to inhibit microbial growth
• Purified water


  Comes from drinking water which was purified through deionization, distillation, ion exchange, reverse osmosis, filtration
• Quality assurance


  Activities ensuring the compound process consistently meets the quality standards
• Quality control


  The testing that ensures the specifications have been met
• Reconstitution


  Process of adding a diluent to a manufactured product to prepare solutions
• Release inspection and testing


  Visual inspection and testing performed to ensure that a preparation meets appropriate quality characteristics
• Sanitizing agent


  Agent for reducing microorganisms
• SDS

  Safety data sheet
• SOP

  Standard operating procedure
• Specification


  The tests, methods, equipment, and materials must conform to its intended use
• Stability


  The extent of a product to retain physical and chemical properties and characteristics throughout its BUD